ZymoGenetics Announces Upcoming Presentation of Positive IL-21 Phase 2 Results in Metastatic Melanoma at ASCO Meeting
Encouraging Objective Response Rate and Progression-Free Survival Estimate Reported in Abstract
Press Release Source: ZymoGenetics, Inc. On Thursday May 20, 2010, 6:10 pm
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News) announced that final progression-free survival results will be presented from a Phase 2 clinical trial in patients with Stage 4 metastatic melanoma at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago on June 5, 2010 in an oral presentation. The open-label multi-center clinical trial evaluated 3 dose regimens of Interleukin 21 (IL-21) in 40 patients with no prior systemic therapy for metastatic melanoma.
The ASCO Annual Meeting abstract reported an overall objective response rate to IL-21 of 24% and median progression-free survival of 5.19 months, which will be updated with the final analysis for the oral presentation. In a historical database of other Phase 2 melanoma studies conducted by the National Cancer Institute of Canada Clinical Trials Group with similar entry criteria, median progression-free survival was 1.58 months. The objective response rate was not dependent on BRAF mutation status. The most common adverse events were fatigue, rash, diarrhea and myalgia. The IL-21 abstract is available at ASCO.org. Updated results will be presented at ASCO.
“We’re encouraged by the progression-free survival and response rate in patients with advanced melanoma,” said Eleanor L. Ramos, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “We selected 30µg/kg/day as the dose for further investigation and are planning a randomized Phase 2b study with the National Cancer Institute of Canada Clinical Trials Group that will seek to further validate the efficacy of IL-21 as a treatment for metastatic melanoma.”
ASCO Oral Presentation
Abstract title: Interleukin-21(IL-21) has activity in patients (pts) with metastatic melanoma (MM)
Abstract #: 8507
Presenter: Teresa Petrella, MD, MSc, FRCPC, Odette Cancer Centre, NCIC Clinical Trials Group
Date: June 5, 2010
Time: 2:00 p.m.
Place: S406 (Vista Room)
About Interleukin 21 (IL-21)
Interleukin 21 (IL-21) is a cytokine that modifies the function of cells in the immune system. IL-21 activates several types of immune cells thought to be critical in eliminating cancerous or virally infected cells from the body. Specifically, IL-21 enhances the activity of natural killer cells and has multiple effects on cytotoxic T cells. This novel immunotherapy has demonstrated antitumor activity in multiple tumor types (metastatic melanoma, renal cell cancer and non-Hodgkin's lymphoma) as a single agent and in combination with other therapies. More than 250 patients have been treated in clinical trials with IL-21. The lead indication is metastatic melanoma, where IL-21 has shown efficacy and there is no consensus standard of care.
surf's up......crikey
